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Involvement of the areola and nipple in women with Breast Cancer: what clinical exams, imaging, and surgical analysis reveal

Aerolopapillary complex involvement in Breast Cancer patients: correlation between clinical, radiological and pathological findings in Mastectomy specimens

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-6n3crpc
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-03-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Interventions

The study will be conducted as a single-arm cohort, without randomization. The sample size calculation indicated that 274 specimens would be sufficient to estimate a proportion of 21.1% with a 95% con
C04.588.180

Sponsors

Hospital Israelita Albert Einstein - São Paulo
Lead Sponsor
Hospital Israelita Albert Einstein - São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women over 18 years old with a diagnosis of Breast Carcinoma; Women with an indication for Mastectomy with excision of the nipple-areola complex

Exclusion criteria

Exclusion criteria: Nipple-areola complex presenting with clinical ulceration; Inflammatory carcinoma; Treatment performed at another institution; Refusal to sign the Informed Consent Form

Design outcomes

Primary

MeasureTime frame
To evaluate whether clinical and radiological factors may be associated with pathological involvement of the nipple–areola complex graft in mastectomy specimens.—

Secondary

MeasureTime frame
To evaluate the accuracy of intraoperative pathological examination of the retroareolar margin, comparing it with the definitive pathological analysis of the specimen.—

Countries

Brazil

Contacts

Public ContactGabriel DAlessandro

Hospital Israelita Albert Einstein - São Paulo

dr.gabriel.dalessandro@gmail.com+55 11 2151-5654

Outcome results

None listed

Source: REBEC (via WHO ICTRP)